Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules. Princessiccia

Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules. Princessiccia

conflicts of interest NIH

Gusty 13:34 Add Comment

The question of whether the NIH should soften its now stringent conflict of interest rules re-surfaced in an editorial in the Hartford Courant. Some choice quotes:

"Prodded by newspaper exposes and congressional inquiries, the NIH instituted a series of reforms. Scientists were barred from accepting compensation from the biomedical industry. Also, the NIH's top 7,000 staffers were prohibited from owning stock in individual medical companies, while all other employees were directed to limit their holdings to $15,000."

"The stock restrictions have raised the ire of a group calling itself the Assembly of Scientists, whose members have threatened to leave the NIH if the reforms aren't scaled back. Health and Human Services Secretary Mike Leavitt, who oversees the NIH, said he's considering their request, calling it a would-be 'softening of the conflict-of-interest policy.'

"In truth, it's more like selling out. Fortunes can be made or lost in biomedical stocks, based on the development or demise of breakthrough drugs and treatments. If researchers were allowed to replenish their portfolios with drug industry stocks, the temptations and biases of recent years would return in force. Mr. Leavitt should stand pat. The NIH's conflict-of-interest policy doesn't need any loopholes blown through it. "

Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules.Princessiccia

Princess Health and Editorial Argues Against Softening NIH Conflict of Interest Rules.Princessiccia

conflicts of interest NIH

Gusty 13:34 Add Comment

The question of whether the NIH should soften its now stringent conflict of interest rules re-surfaced in an editorial in the Hartford Courant. Some choice quotes:

"Prodded by newspaper exposes and congressional inquiries, the NIH instituted a series of reforms. Scientists were barred from accepting compensation from the biomedical industry. Also, the NIH's top 7,000 staffers were prohibited from owning stock in individual medical companies, while all other employees were directed to limit their holdings to $15,000."

"The stock restrictions have raised the ire of a group calling itself the Assembly of Scientists, whose members have threatened to leave the NIH if the reforms aren't scaled back. Health and Human Services Secretary Mike Leavitt, who oversees the NIH, said he's considering their request, calling it a would-be 'softening of the conflict-of-interest policy.'

"In truth, it's more like selling out. Fortunes can be made or lost in biomedical stocks, based on the development or demise of breakthrough drugs and treatments. If researchers were allowed to replenish their portfolios with drug industry stocks, the temptations and biases of recent years would return in force. Mr. Leavitt should stand pat. The NIH's conflict-of-interest policy doesn't need any loopholes blown through it. "

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?. Princessiccia

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?. Princessiccia

hospitals non-profit organizations

Gusty 13:32 Add Comment

The Baltimore Sun reports that both the US House of Representatives Ways and Means Committee and the Senate Finance Committee are opening enquiries about whether US not-for-profit hospitals should keep their tax exemptions.
Rep. Bill Thomas (R-California) said, "We really can't tell the difference, all that much, between a for-profit and a not-for-profit. What is the taxpayer getting in return for the tens of billions of dollars per year in tax subsidy?" Sen. Charles Grassley (R-Iowa) said "It's also my job to make sure charities are earning their generous tax breaks. Tax-exempt status is a privilege."
Mark Everson, Commissioner of the Internal Revenue Service, testified "We at the IRS are now faced with a health care industry in which it is increasingly difficult to differentiate for-profit from nonprofit health care providers." The article further explained, "IRS reviews have turned up questions about excessive executive compensation, complex ventures with profitable companies, employment taxes and operations benefiting a private, not public good."
I am not surprised that politicians are beginning to question why supposedly "not-for-profit" hospitals should keep their privileged status. Since I first did the interviews that resulted in my European Journal of Internal Medicine article on health care dysfunction, I have heard about case after case about questionable leadership of large health care organizations, including many that involved not-for-profit hospitals. Just this month, for example, Health Care Renewal postings have included cases of :

• exaggerated and possibly misleading advertising (here and here);
• charging inflated "list prices," since managed care organizations think they are getting a bargain when they apply fixed discounts to whatever the hospitals want to charge, even if poor, uninsured patients are then charged full "list prices" (see here, here, and here); and
• miscellaneous fraud involving Medicaid billing (here), and construction kickbacks (here)

all involving not-for-profit hospitals.
Of course, ending all not-for-profit hospitals' tax exemption would be an exceedingly blunt way to address these problems. I have no doubt that there are many competently and honestly lead hospitals, whose leaders make real efforts to fulfill their missions, and to add real value to their communities. They do not deserve to lose their tax exemptions. However, they risk being thrown in the same bucket with their "bad apple" brethren. Up to now, hospital leaders as a group have not made readily apparent attempts to police their own ranks.
Thus, we need some better watchdog and/or regulatory mechanisms to address ill-informed, conflicted, and corrupt leadership of not-for-profit hospitals, (and of other health care organizations). Perhaps hospital leaders will develop develop a self-policing mechanism. Perhaps these mechanisms could be set up by physicians and other health care professionals, or as part of government regulatory agencies. However, not having these mechanisms means that continuing abuses will tempt politicians to employ indiscriminate, shot-gun approaches which will harm the good apples along with the bad.

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?.Princessiccia

Princess Health and Should US Not-For-Profit Hospitals Lose Their Privileged Status?.Princessiccia

hospitals non-profit organizations

Gusty 13:32 Add Comment

The Baltimore Sun reports that both the US House of Representatives Ways and Means Committee and the Senate Finance Committee are opening enquiries about whether US not-for-profit hospitals should keep their tax exemptions.
Rep. Bill Thomas (R-California) said, "We really can't tell the difference, all that much, between a for-profit and a not-for-profit. What is the taxpayer getting in return for the tens of billions of dollars per year in tax subsidy?" Sen. Charles Grassley (R-Iowa) said "It's also my job to make sure charities are earning their generous tax breaks. Tax-exempt status is a privilege."
Mark Everson, Commissioner of the Internal Revenue Service, testified "We at the IRS are now faced with a health care industry in which it is increasingly difficult to differentiate for-profit from nonprofit health care providers." The article further explained, "IRS reviews have turned up questions about excessive executive compensation, complex ventures with profitable companies, employment taxes and operations benefiting a private, not public good."
I am not surprised that politicians are beginning to question why supposedly "not-for-profit" hospitals should keep their privileged status. Since I first did the interviews that resulted in my European Journal of Internal Medicine article on health care dysfunction, I have heard about case after case about questionable leadership of large health care organizations, including many that involved not-for-profit hospitals. Just this month, for example, Health Care Renewal postings have included cases of :

• exaggerated and possibly misleading advertising (here and here);
• charging inflated "list prices," since managed care organizations think they are getting a bargain when they apply fixed discounts to whatever the hospitals want to charge, even if poor, uninsured patients are then charged full "list prices" (see here, here, and here); and
• miscellaneous fraud involving Medicaid billing (here), and construction kickbacks (here)

all involving not-for-profit hospitals.
Of course, ending all not-for-profit hospitals' tax exemption would be an exceedingly blunt way to address these problems. I have no doubt that there are many competently and honestly lead hospitals, whose leaders make real efforts to fulfill their missions, and to add real value to their communities. They do not deserve to lose their tax exemptions. However, they risk being thrown in the same bucket with their "bad apple" brethren. Up to now, hospital leaders as a group have not made readily apparent attempts to police their own ranks.
Thus, we need some better watchdog and/or regulatory mechanisms to address ill-informed, conflicted, and corrupt leadership of not-for-profit hospitals, (and of other health care organizations). Perhaps hospital leaders will develop develop a self-policing mechanism. Perhaps these mechanisms could be set up by physicians and other health care professionals, or as part of government regulatory agencies. However, not having these mechanisms means that continuing abuses will tempt politicians to employ indiscriminate, shot-gun approaches which will harm the good apples along with the bad.

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors. Princessiccia

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors. Princessiccia

conflicts of interest institutional conflicts of interest manipulating clinical research suppression of medical research

Gusty 12:45 Add Comment

The NEJM article about contracts for clinical trials between academic health centers (AHCs) and pharmaceutical companies mentioned in an earlier post deserves further attention. (The study is available here, and its citation is Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.)

First, let me summarze the study's design. The authors sent a survey to senior administrators in the offices of sponsored research in 122 medical schools. They received responses from 107, for 91% response rate, excluding four schools that did no clinical research. They asked the administrators questions about provisions they would usually allow in contracts between their medical schools and corporate sponsors. The proportions who would allow some particular research practices follow:

• The sponsor will own the data produced by the research - 80%
• The sponsor will store the data and release portions to the investigator - 35%
• The investigators (whether at your site or any other site) are not permitted to alter the study design after the agreement is executed - 68%
• The sponsor is permitted to alter the study design after the agreement is executed - 62%
• The sponsor may prohibit individual site investigators from publishing manuscripts independently of the sponsor or group - 15%
• The sponsor may include its own statistical analysis in manuscripts - 24%
• The sponsor will write up the results for publication and the investigators may review the manuscript and suggest revisions - 50%
• While the trial is going on, the investigators may not discuss research results (including presentations at scientific meetings) with people not involved in the trial - 66%
• After the trial is over, the investigators may not discuss research results (including presentations at scientific meetings) until the sponsor consents to dissemination - 21%
• The terms of the clinical-trial agreement are confidential - 62%
• After the trial is over, the industry sponsor may prohibit investigators from sharing raw research data with third parties - 41%

In summary, this study suggests that some medical schools will acquiesce to contracts that prevent their faculty from having meaningful control over research projects for which they are the ostensible investigators. Some medical schools will allow corporate research sponsors to manipulate the design, analysis, and interpretation of results to increase the likelihood of getting the results the sponsor wants. For example, 50% of medical schools would allow the corporate sponsor to write manuscripts reporting on study results, and only allow faculty to "suggest revisions." Thus, many medical schools acquiesce to contracts that could allow corporate sponsors to ghost-write articles. Furthermore, more than half of the medical schools acquiesce to contracts that are kept confidential, preventing easy discovery of manipulation of the conduct and dissemination of the research by the corporate sponsor.
(To see specific techniques that corporate sponsors may use to increase the likelihood that research produces the results they want, see our earlier post about the article entitled "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies" by Richard Smith.)
To underline the context, in my experience, to do clinical research, most medical school faculty are strongly pressured by their institutions to obtain external funding to support this work. Those who cannot obtain funding within a few years of unemployment often have to find something else to do other than research. However, although faculty are expected to find sources of funding, it is generally the medical schools or academic medical centers, not the researchers, who negotiate research agreements, and although such agreements may bind faculty members, the money paid under their auspices generally goes directly to the faculty member's employer. Thus, individual researchers are under considerable pressure to find grant and contract funding, and to keep their financial sponsors happy, but must work under whatever contract provisions their employers negotiate.
The New England Journal of Medicine article clearly suggests that some medical schools allow researchers to be bound by agreements that allow the study's sponsor to manipulate study design, analysis, and interpretation to make it more likely that the results will be to the sponsor's liking. Since clinical trials enroll real human beings as subjects with the promise that the data they contribute, and the risks they run, will lead to valid scientific results, allowing such manipulation appears to not only likely to produce biased results, but also to be allow unethical exploitation of human subjects, and thus is in conflict with the medical school's scientific and humanitarian mission.
This is yet another illustration of leaders of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
One can only hope that publicizing such practices will lead to more ethical research, and less exploitation of human subjects.
By the way, I do not in any sense mean to blame the research administrators who must try to negotiate these contracts. Note that 69% of the administrators "perceived that competition for research funds created pressure on administrators to compromise on the language of the contract." 24% described the pressure as "great." I do blame the higher leadership of the medical schools for fostering a climate in which money is more important than doing valid, ethical research. This raises several important questions:

• Why don't some medical school leaders enforce clearer ethical standards for clinical research sponsored by industry?
• Are they so worried about getting the money, and so worried that they will lose contracts if they insist on ethical standards?
• Are they so steeped in the exteme relativism of the post-modernist university that they don't believe in such standards?
• Are they so used to violating their own mission to support political causes, as is documented again and again on the FIRE web-site, that they aren't troubled by violating their mission for economic reasons?

Maybe it's time we start trying to address such questions.

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors.Princessiccia

Princess Health and A Troubling Study of the Contracts Between Medical Schools and Corporate Research Sponsors.Princessiccia

conflicts of interest institutional conflicts of interest manipulating clinical research suppression of medical research

Gusty 12:45 Add Comment

The NEJM article about contracts for clinical trials between academic health centers (AHCs) and pharmaceutical companies mentioned in an earlier post deserves further attention. (The study is available here, and its citation is Mello MM, Clarridge BR, Studdert DM. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.)

First, let me summarze the study's design. The authors sent a survey to senior administrators in the offices of sponsored research in 122 medical schools. They received responses from 107, for 91% response rate, excluding four schools that did no clinical research. They asked the administrators questions about provisions they would usually allow in contracts between their medical schools and corporate sponsors. The proportions who would allow some particular research practices follow:

• The sponsor will own the data produced by the research - 80%
• The sponsor will store the data and release portions to the investigator - 35%
• The investigators (whether at your site or any other site) are not permitted to alter the study design after the agreement is executed - 68%
• The sponsor is permitted to alter the study design after the agreement is executed - 62%
• The sponsor may prohibit individual site investigators from publishing manuscripts independently of the sponsor or group - 15%
• The sponsor may include its own statistical analysis in manuscripts - 24%
• The sponsor will write up the results for publication and the investigators may review the manuscript and suggest revisions - 50%
• While the trial is going on, the investigators may not discuss research results (including presentations at scientific meetings) with people not involved in the trial - 66%
• After the trial is over, the investigators may not discuss research results (including presentations at scientific meetings) until the sponsor consents to dissemination - 21%
• The terms of the clinical-trial agreement are confidential - 62%
• After the trial is over, the industry sponsor may prohibit investigators from sharing raw research data with third parties - 41%

In summary, this study suggests that some medical schools will acquiesce to contracts that prevent their faculty from having meaningful control over research projects for which they are the ostensible investigators. Some medical schools will allow corporate research sponsors to manipulate the design, analysis, and interpretation of results to increase the likelihood of getting the results the sponsor wants. For example, 50% of medical schools would allow the corporate sponsor to write manuscripts reporting on study results, and only allow faculty to "suggest revisions." Thus, many medical schools acquiesce to contracts that could allow corporate sponsors to ghost-write articles. Furthermore, more than half of the medical schools acquiesce to contracts that are kept confidential, preventing easy discovery of manipulation of the conduct and dissemination of the research by the corporate sponsor.
(To see specific techniques that corporate sponsors may use to increase the likelihood that research produces the results they want, see our earlier post about the article entitled "Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies" by Richard Smith.)
To underline the context, in my experience, to do clinical research, most medical school faculty are strongly pressured by their institutions to obtain external funding to support this work. Those who cannot obtain funding within a few years of unemployment often have to find something else to do other than research. However, although faculty are expected to find sources of funding, it is generally the medical schools or academic medical centers, not the researchers, who negotiate research agreements, and although such agreements may bind faculty members, the money paid under their auspices generally goes directly to the faculty member's employer. Thus, individual researchers are under considerable pressure to find grant and contract funding, and to keep their financial sponsors happy, but must work under whatever contract provisions their employers negotiate.
The New England Journal of Medicine article clearly suggests that some medical schools allow researchers to be bound by agreements that allow the study's sponsor to manipulate study design, analysis, and interpretation to make it more likely that the results will be to the sponsor's liking. Since clinical trials enroll real human beings as subjects with the promise that the data they contribute, and the risks they run, will lead to valid scientific results, allowing such manipulation appears to not only likely to produce biased results, but also to be allow unethical exploitation of human subjects, and thus is in conflict with the medical school's scientific and humanitarian mission.
This is yet another illustration of leaders of powerful health care organizations acting in conflict with physicians' and medical researchers' core values.
One can only hope that publicizing such practices will lead to more ethical research, and less exploitation of human subjects.
By the way, I do not in any sense mean to blame the research administrators who must try to negotiate these contracts. Note that 69% of the administrators "perceived that competition for research funds created pressure on administrators to compromise on the language of the contract." 24% described the pressure as "great." I do blame the higher leadership of the medical schools for fostering a climate in which money is more important than doing valid, ethical research. This raises several important questions:

• Why don't some medical school leaders enforce clearer ethical standards for clinical research sponsored by industry?
• Are they so worried about getting the money, and so worried that they will lose contracts if they insist on ethical standards?
• Are they so steeped in the exteme relativism of the post-modernist university that they don't believe in such standards?
• Are they so used to violating their own mission to support political causes, as is documented again and again on the FIRE web-site, that they aren't troubled by violating their mission for economic reasons?

Maybe it's time we start trying to address such questions.

Princess Health and Wall Street Journal: Medical Editor Turns Activist On Drug Trials. Princessiccia

Princess Health and Wall Street Journal: Medical Editor Turns Activist On Drug Trials. Princessiccia

Gusty 08:39 Add Comment

NEJM editor Drazen returns to the Light Side of the Force. The revelation about academic medical centers willingly accepting ghost-writing or marginalization of their faculty as principal authors is stunning.

JEFFREY DRAZEN, editor of the prestigious New England Journal of Medicine, has prescribed a strong dose of disclosure for the pharmaceutical industry he was once accused of embracing too closely.

This week, Dr. Drazen accused three big pharmaceutical companies of "making a mockery" of a government database designed to provide accessible information about drug trials. He also joined a dozen other medical-journal editors in again warning that they might refuse to publish studies that don't adhere to their disclosure demands. Dr. Drazen has also recently written, and his journal has published, pieces critical of companies suppressing negative information about drug trials.

And the journal today plans to publish a study suggesting that drug companies may be exerting more influence over the supposedly independent academic investigators that they hire to conduct drug trials than had previously been known. The study, a survey of 107 medical-school research centers, shows that half would allow sponsors of their research to draft manuscripts reporting the results while limiting the role of the investigator to suggesting revisions.

... Dr. Drazen's newfound activism is especially striking since he came under fire for his own financial ties to the pharmaceutical industry when he took his current job at the New England Journal five years ago.

"He's been converted," said Marcia Angell, senior lecturer at Harvard Medical School and Dr. Drazen's predecessor as editor-in- chief. "Through painful experience, Jeff is learning what these companies are about. He sees the ugly side that he hadn't seen before -- the bias that company-sponsored research contains, the suppression of results that they don't like, the spin of unfavorable results."

-- SS